Treatment To Prevent Fractures in Men and Women With Low Bone Density or Osteoporosis: An Update
Summary of Study Characteristics Evaluated in the Effectiveness Review: PICOTS
Development of clinical studies of effectiveness of medical interventions is guided by the PICOTS (population, interventions, comparators, outcomes, timing, and setting) framework. These items are critical elements that will help to answer important clinical questions. In the CER, the clinical study literature was reviewed and summarized by using the PICOTS framework. The evidence concerning the outcomes identified here was examined in:
Population: Adults over 18 including healthy adults, those with LBD, those with osteoporosis, and adults at risk of LBD and osteoporosis due to chronic use of glucocorticoids or as a result of a condition associated with LBD (e.g. rheumatoid arthritis, cystic fibrosis, Parkinson’s disease).
Interventions: Pharmacological interventions for prevention or treatment of osteoporosis approved or soon to be approved by the FDA, calcium, vitamin D, or physical activity.
Comparators: Placebo, other doses, other agents in the same or another class
Outcomes: Vertebral, hip, and total fractures, fractures reported as outcomes, not as adverse events
Timing: Minimum of 6 months
Setting: All settings
Keywords: alendronate | bisphosphonate | bone | bone density | calcium | calcium | denosumab | fracture | glucocorticoids | hip | ibandronate | LBD | low bone density | nonvertebral | osteopenia | osteoporosis | physical activity | postmenopausal | raloxifene | risedronate | risk | skeletal | teriparatide | vertebral | vitamin D | wrist | zoledronic acid | PICOTS
- Newberry SJ, Crandall CC, Gellad WG, et al. Treatment To Prevent Fractures in Men and Women With Low Bone Density or Osteoporosis: An Update to the 2007 Report. Comparative Effectiveness Review No. 53 (Prepared by the Southern California Evidence-based Practice Center under Contract No. HHSA 290-2007-10062-I). Rockville, MD: Agency for Healthcare Research and Quality; February 2012. AHRQ Publication No. 12-EHC023-EF. Available at www.effectivehealthcare.ahrq.gov/reports/lbd.cfm.
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